Shawn D. Walker

Shawn D. Walker Email and Phone Number

VP and Global Head of Synthetics CMC Development @ Sanofi
Boston, MA, US
Shawn D. Walker's Location
Greater Boston, United States, United States
Shawn D. Walker's Contact Details

Shawn D. Walker personal email

n/a

Shawn D. Walker phone numbers

About Shawn D. Walker

Summary:Passionate pharmaceutical development leader with extensive experience in the biotech / pharma industry. Proven track record of scientific accomplishment, leadership, innovation and development of high-performing teams. Experience spanning pre-clinical, clinical and commercial drug development phases including commercial process design, characterization, validation and global regulatory filings. Demonstrated scientific eminence via international conference presentations, publications in peer reviewed journals and thousands of citations in the chemical literature.Disclaimer: The postings on this site are my own and do not necessarily represent Sanofi’s positions, strategies, or opinions.

Shawn D. Walker's Current Company Details
Sanofi

Sanofi

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VP and Global Head of Synthetics CMC Development
Boston, MA, US
Website:
sanofi.com
Employees:
88327
Shawn D. Walker Work Experience Details
  • Sanofi
    Vp And Global Head Of Synthetics Cmc Development
    Sanofi
    Boston, Ma, Us
  • Sanofi
    Vp / Global Head Of Synthetics Cmc Development
    Sanofi Feb 2023 - Present
    Paris, France, Fr
    Global Head of Sanofi’s Synthetics Development Platform. Responsibilities include all aspects of synthetic / small molecule drug development from candidate selection to product approval, encompassing drug substance, drug product and analytical development, DS/DP clinical manufacturing and regulatory document authoring from IND submission to NDA approval. The Synthetics R&D organization includes teams in France (Montpellier, Sisteron & Paris/Vitry), Germany (Frankfurt) and the United States (Cambridge).
  • Veranova
    Svp Development Operations & Cto
    Veranova Jun 2022 - Feb 2023
    Wayne, Pennsylvania, Us
    Senior Vice President, Development Operations & Chief Technology Officer at Veranova. Formerly Johnson Matthey Health, Veranova launched as an independent company on June 1, 2022. Veranova is a global leader in process development and manufacturing of APIs, with a focus on specialty and complex products. Veranova is headquartered in Wayne, PA and has operations in North America, Europe, and Asia.
  • Johnson Matthey
    Vice President, Development Operations - Health Sector
    Johnson Matthey Oct 2019 - Jun 2022
    London, Greater London, Gb
    VP of Development Operations for the Health Sector. Development Operations is the science and drug development engine of JM Health and comprises Chemical Development, Analytical Development, Solid Form Sciences & Particle Engineering, Generic API / Finished Dosage Form Development, New Product Introduction and Operations Excellence.Highlights:• Led an organization of >195 scientists and engineers across five sites in the US & UK • Expertise in development of complex small molecules, potent compounds, and controlled substances for JM’s proprietary portfolio of generic APIs & CDMO services for originator partners• Responsible for >50 pipeline products (generic & originator) across all phases of development (preclinical to commercial launch), spanning small molecules, oligonucleotides, ADC linker/warheads, cannabinoids, alkaloids, and diverse heterocyclics• Member of the corporate R&D Leadership Team• Member of Steering Committee for Key Innovation Programs• Member of Health Sector Executive Committee
  • Amgen
    Director, Synthetic Technologies And Engineering
    Amgen 2015 - 2019
    Thousand Oaks, Ca, Us
    Head of the Synthetic Technologies and Engineering group at Amgen. Led an organization responsible for the development of efficient and cost-effective chemical manufacturing processes that delivered drug substance that met the QTPP for Amgen products. Worked closely with attribute sciences, drug product technologies and partners in the manufacturing network to achieve safe and robust processes designed with the end in mind. My group’s core capabilities included synthetic route design, optimization, process development and characterization, crystallization, safety (thermal hazards evaluation), process engineering, modeling, tech transfer and plant fit.Highlights:• Led a group of >40 chemists & chemical engineers across two sites (Cambridge/Thousand Oaks)• Accountability for drug substance process development of Amgen’s synthetic and hybrid modalities including small molecules, synthetic peptides, ADCs, siRNA and novel hybrid molecules within the Pivotal DS Technologies organization• Responsibilities included managing a portfolio of clinical drug candidates, project teams & supporting infrastructure including the synthetic scale-up labs, thermal hazards evaluation lab, automation platforms, predictive modeling, machine learning & continuous manufacturing development• Extensive experience in drug substance process design, tech transfer, PPQ, regulatory filings and life cycle management on multiple commercial products and numerous clinical candidates• Strong track record in the development of novel, robust and safe chemistry for the manufacture of active pharmaceutical ingredients including synthetic route design, catalysis, form selection (salt, polymorph), particle size & milling strategies, PAT applications, risk assessments and validation• Successful in managing organizational strategy and budget, cross-functional CMC teams, external CMO network activities, industry/academic collaborations, and recruitment of top talent
  • Amgen
    Principal Scientist
    Amgen 2011 - 2015
    Thousand Oaks, Ca, Us
    CMC Team Lead (integrated team consisting of members from Process R&D, Pharmaceutical R&D, Analytical R&D, Quality and Regulatory Affairs): responsible for strategy and technical development related to the manufacture and release of drug substance and drug product. Drug Substance Team Lead: responsible for the development of novel, robust and safe chemistry for the manufacture of active pharmaceutical ingredients. Route selection, optimization, final form selection (salt, polymorph) and GMP scale-up of drug substance. Correlation/control of drug substance bulk properties to aid drug product manufacture and performance. CMC Module 3 authoring for regulatory filings, tech transfer to CMO’s, authoring for patents and publications in peer-reviewed journals. DS Lead for Corlanor®, the first new chronic heart failure medicine approved by the FDA in nearly a decade.
  • Amgen
    Sr. Scientist
    Amgen 2007 - 2011
    Thousand Oaks, Ca, Us
  • Amgen
    Scientist
    Amgen 2004 - 2007
    Thousand Oaks, Ca, Us
  • Merck
    Research Chemist
    Merck 1995 - 1995
    Medicinal Chemistry research at Merck Frosst focused on the development of a 'traceless' silicon based linking technology for solid phase synthesis. A method was devised for attaching haloarylsilanes to a polymer support that could then be cleaved by a variety of electrophiles (e.g. H+, ICl, Br2) to give the desired ipso-substitution products. Suzuki cross-coupling reactions on the polymer bound haloarylsilanes were also performed. High yields of biaryls were obtained upon electrophilic cleavage of the coupled resins and an exploration of other aromatic scaffolds for rapid analogue synthesis was conducted.

Shawn D. Walker Skills

Chemistry Organic Synthesis Organic Chemistry Gmp Drug Development Synthetic Organic Chemistry Drug Design Drug Discovery Small Molecules Hplc Technology Transfer Pharmaceutical Industry Medicinal Chemistry R&d Organometallic Chemistry Biotechnology Protein Chemistry Ind Crystallization Catalysis Fda Regulatory Submissions Life Sciences Biopharmaceuticals High Performance Liquid Chromatography Glp Validation Research And Development Strategy Cmc Management Leadership Strategic Planning Staff Development Cmo Management Cmc Development Cmc Regulatory Affairs Process Design Manufacturing Processes Commercialization Characterization Process Engineering Analytical Chemistry Machine Learning

Shawn D. Walker Education Details

  • Massachusetts Institute Of Technology
    Massachusetts Institute Of Technology
    Organic/Organometallic Chemistry
  • The University Of British Columbia
    The University Of British Columbia
    Organic Chemistry
  • Mcgill University
    Mcgill University
    Chemistry
  • Cegep - John Abbott College
    Cegep - John Abbott College
    Pure And Applied Science

Frequently Asked Questions about Shawn D. Walker

What company does Shawn D. Walker work for?

Shawn D. Walker works for Sanofi

What is Shawn D. Walker's role at the current company?

Shawn D. Walker's current role is VP and Global Head of Synthetics CMC Development.

What is Shawn D. Walker's email address?

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What is Shawn D. Walker's direct phone number?

Shawn D. Walker's direct phone number is (805) 447*****

What schools did Shawn D. Walker attend?

Shawn D. Walker attended Massachusetts Institute Of Technology, The University Of British Columbia, Mcgill University, Cegep - John Abbott College.

What are some of Shawn D. Walker's interests?

Shawn D. Walker has interest in Science And Technology, Education, Health.

What skills is Shawn D. Walker known for?

Shawn D. Walker has skills like Chemistry, Organic Synthesis, Organic Chemistry, Gmp, Drug Development, Synthetic Organic Chemistry, Drug Design, Drug Discovery, Small Molecules, Hplc, Technology Transfer, Pharmaceutical Industry.

Who are Shawn D. Walker's colleagues?

Shawn D. Walker's colleagues are Hakim Chekroune, Sylvie Belzons, Inmaculada Fuentes, Kaouther Aidoun, Akash Singh, Jean-Jacques Lépine, Dominique Angelini.

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